Clinical Trial

RCT of EFTR Versus STER for GIST Treatment

Recruiting
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Summary
Endoscopic resection has been increasing utilized as the treatment for small size gastrointestinal stromal tumors (GIST), of which the best resection method has not been identified. We aim to compare the outcomes of endoscopic full thickness resection (EFTR) versus submucosal tunnelling endoscopic resection (STER) for clinical small gastric GIST. We hypothesize that EFTR could achieve better complete margin negative resection than STER without increase in adverse event. This is an international multi-center double blinded randomized controlled trial involving four high volume centers from Hong Kong, mainland China, India and Japan. Adult patients with clinical 1.0-3.Scm gastric GIST undergoing endoscopic resection would be recruited. Patients would be randomized to undergo EFTR (intervention) or STER (Control) by expert endoscopists under general anaesthesia according to well published methods.
Trial Details
NCT Number NCT07411118
Lead Sponsor Chinese University of Hong Kong
Collaborators: Fudan University, Osaka International Cancer Institute, Asian Institute of Gastroenterology, India
Conditions Small Size Gastrointestinal Stromal Tumors, GIST
Enrollment 136 participants
Start Date 2025-02-01
Primary Completion 2032-12-01 (estimated)
Study Completion 2033-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-13